NCT01545375 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hammitt LL, Campbell JC, Borys D, Weatherholtz RC, Reid R, Goklish N, Moulton LH, Traskine M, Song Y, Swinnen K, Santosham M, O'Brien KL
Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study. Vaccine. 2019 Dec 3;37(51):7482-7492. doi: 10.1016/j.vaccine.2019.09.076. Epub 2019 Oct 16.

Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

Clinical trial NCT01545375 - References